Fresh Versus Frozen Stool for Fecal Transplant in Children

NCT ID: NCT02423967

Last Updated: 2019-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2019-03-04

Brief Summary

The primary goal of this study will be to assess whether stool collected and frozen from anonymous screened unrelated donors can be as effective as stool freshly collected from recipient's parents when used in Fecal Microbial Transplant for the eradication of recurrent Clostridium difficile infections in children. In the current protocols, which are more than 90% effective, each child who is receiving a fecal transplant has to provide their own donor stool, usually from a parent or close relative. This requires considerable screening costs for each case and is logistically complicated as the donor must be present and must stool just prior to the transplant. The investigators hope to show that a small number of healthy donors can provide stool samples which can be frozen and banked and then thawed for use in numerous patients. The primary goal is to show that Clostridium difficile will be eradicated as effectively (Greater than 90% success) when using the stool from the frozen donors.

The study will also evaluate the inflammatory response and intestinal microbiome in young children aged 1-3 years with Clostridium difficile infections to better predict which ones will respond to fecal transplantation and which ones have incidental infections. For this question the investigators will gather stool samples to check for lactoferrin, calprotectin, and alpha1antitrypsin, and 16s ribosomal RNA analysis in children before and after the fecal transplants. The goal is to see if there is an intestinal microbiome that predisposes some children to getting sick from Clostridium difficile versus just having it incidentally.

Detailed Description

The study is designed to enroll forty children aged 1-18 with recurrent Clostridium difficile Infection (CDI). Recurrent CDI is defined as an infection that persists after three rounds of appropriate antibiotics. Enrollees will be randomly assigned to receive Fecal Microbial Transplant using stool from either a screened relative as per current protocols versus using frozen stool that has been collected from healthy volunteers.

Primary outcome will be the eradication of the Clostridium difficile as defined by elimination of diarrhea with a negative Clostridium difficile toxin stool test.

Secondary outcomes will include a measure of quality of life pre and post Fecal Microbial Transplant using a validated quality of life survey instrument, the Health Act Child Health Questionnaire. The investigators will also assess for inflammation in the stool using lactoferrin and calprotectin and evaluate the stool microbiome in recipients pre and post transplant using sequencing to look for any pattern that predicts successful eradication.

Conditions

Clostridium Difficile

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transplant uses fresh familial stool

Undergoes Fecal Microbial Transplant using fresh stool from a screened family member Followed up and assessed for eradication of Clostridium difficile Quality of life assessed Stool assessed for inflammation and microbiome

Group Type: ACTIVE_COMPARATOR

Transplant uses fresh familial stool

Intervention Type: BIOLOGICAL

The intervention is using fresh familial donor stool for the fecal microbial transplant to treat recurrent CDI

Transplant uses frozen anonymous stool

Undergoes Fecal Microbial Transplant using stool collected from screened anonymous donor that has been frozen until time of Fecal Microbial Transplant Followed up and assessed for eradication of Clostridium difficile Quality of life assessed Stool assessed for inflammation and microbiome

Group Type: EXPERIMENTAL

Transplant uses frozen anonymous stool

Intervention Type: BIOLOGICAL

The intervention is using frozen anonymous donor stool instead of fresh stool from family members for the fecal microbial transplant to treat recurrent CDI.

Interventions

Transplant uses frozen anonymous stool

The intervention is using frozen anonymous donor stool instead of fresh stool from family members for the fecal microbial transplant to treat recurrent CDI.

Intervention Type: BIOLOGICAL

Transplant uses fresh familial stool

The intervention is using fresh familial donor stool for the fecal microbial transplant to treat recurrent CDI

Intervention Type: BIOLOGICAL

Other Intervention Names

fecal microbial transplant; fecal microbila transplant

Eligibility Criteria

Inclusion Criteria

• Age 1-18 years
• Diarrhea
• Positive Clostridium difficile infection using stool toxin testing
• Diarrhea that has improved on antibiotics but recurs when antibiotics are stopped.
• Willingness to undergo Fecal Microbial Transplant using frozen stool from anonymous screened donors.

Exclusion Criteria

• Age under 1 or over 18
• No diarrhea

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mark G. Bartlett, M.D.

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Bartlett, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

14-004472

Identifier Type: -

Identifier Source: org_study_id